Rezafungin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: HAFIZA AMNA QADEER
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Rezafungin is an ANTIFUNGAL ECHINOCANDIN that is FDA approved for the treatment of patients with invasive candidiasis and candidemia who are at least 18 years old and have few or no other options for treatment.. Common adverse reactions include Diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage of rezafungin is once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of rezafungin has not been established beyond 4 weekly doses. Rezafungin is used for intravenous infusion only. Administer rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Rezafungin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
Warnings
There is limited information regarding Rezafungin Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
The following adverse reaction can occur after administration of rezafungin:
GASTROINTESTINAL
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
METABOLISM AND NUTRITION DISORDER
Anemia, Disseminated Intravascular Coagulation.
NERVOUS SYSTEM
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
INTEGUMENTARY SYSTEM
Photosensitivity and erythema.
CARDIOVASCULAR SYSTEM
Fluid overload.
Postmarketing Experience
There is limited information regarding Rezafungin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Rezafungin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rezafungin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rezafungin during labor and delivery.
Nursing Mothers
There are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric Use
The safety and effectiveness of rezafungin have not been established in pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Rezafungin in geriatric settings.
Gender
Clinical studies of rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
Race
There is no FDA guidance on the use of Rezafungin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rezafungin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rezafungin in patients with hepatic impairment.
Females of Reproductive Potential and Males
The effect of rezafungin on human fertility is unknown.
Immunocompromised Patients
There is no FDA guidance one the use of Rezafungin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Rezafungin Administration in the drug label.
Monitoring
There is limited information regarding Rezafungin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Rezafungin and IV administrations.
Overdosage
No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
Pharmacology
There is limited information regarding Rezafungin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Rezafungin Mechanism of Action in the drug label.
Structure
There is limited information regarding Rezafungin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Rezafungin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Rezafungin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Rezafungin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Rezafungin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Rezafungin How Supplied in the drug label.
Storage
There is limited information regarding Rezafungin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Rezafungin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Rezafungin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
REZZAYO
Look-Alike Drug Names
There is limited information regarding Rezafungin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.